Schanler 1999.
Methods | Randomised controlled trial | |
Participants | Infants 26 to 30 weeks' gestation whose birth weight was appropriate for gestational age, who had no major congenital anomalies Setting: Texas Children's Hospital, Texas, USA |
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Interventions | Minimal enteral nutrition (N = 82) vs. enteral fasting (N = 89). The minimal enteral feeding group received 20 ml/kg/day of expressed breast milk or half‐strength preterm formula from day 4 to 14 after birth | |
Outcomes | Feeding tolerance; days to full enteral feeding Incidence of necrotising enterocolitis Time to regain birth weight and growth parameters during hospital admission Incidence of invasive infection Mortality |
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Notes | This study used a factorial design in which infants were randomised to 4 groups (continuous minimal enteral feeds, intermittent bolus minimal enteral feeds, enteral fasting followed by continuous feeding, enteral fasting followed by bolus feeding) to allow simultaneous assessment of the use of both minimal enteral nutrition and continuous feedings vs. bolus. In this review, Schanler 1999 refers to outcomes reported for all infants in trophic feedings group vs. all control infants [February 2009: mortality data received from Dr Schanler.] [June 2012: incidence of infection data received from Dr Schanler] |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Stratification by gestational age and type of milk followed by randomisation using sealed opaque envelopes |
Allocation concealment (selection bias) | Low risk | Adequate given the use of sealed envelopes |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Care givers and investigators not blinded following randomisation |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not described |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Intention‐to‐treat analysis |